ISO 13485 Audit help needed

I

ILyAS

#11
We change only SOPs, issue new version. What you named "master copy" not changed, it's general document.
 
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K

Ktrna

#12
This brings up another issue I am unclear about. (Please excuse my ignorance I am extremely new to all this and as I mentioned, there is no guidance within the company regarding these issues) I have a master copy of the index and document responsibility list. The previous person would issue a new revision number each time she revised a document within this list. If the format of the list hasn't changed is it necessary to issue a new revision number? I am sure this is basic information someone doing this job should know but I must learn from experience...
 
L

Laura Halper

#13
Given the amount of work you seem to have inherited, I suggest that you write down a plan in which you identify the major tasks that need to be done, and put them in priority order. This should have two benefits. First, it will help you organize your thoughts. Right now things may look overwhelming, but getting a plan on paper will help you focus your time.

Second, an auditor will look much more favorably on a bad situation if you yourself have already identified the deficiencies and have a written plan to fix them. Even better if you have knocked off a few items before the ISO audit. The auditor may just issue you a Minor Nonconformance for a given deficiency, instead of a Major Nonconformance, if you can show that you are in the process of addressing the issue.

Regarding the master list of documents and responsibilities, I don't see that any value is added by putting the master list through an approval process each time a document on the list is revised. But you do need some way to know which version of the list you are looking at. If you don't want to issue a new revision each time, then I'd suggest at least dating the list and changing the date whenever a document on the list is revised.
 
A

arios

#15
You can keep the master list electronic, and protected with a password so only you can revise it and update it
 
P

pangchiaboon

#16
I have a lot to change, revise, update and/or totally redo with our quality manual. Although I have received notice outlining the areas of the audit I am finding it difficult to just "fix" those areas because they obviously relate to other sections in the quality manual.
Hi, i understand your situation now and i have gone through the same situation in the past. I suggest you do not change the manual / procedure, because you will get them MESS UP some more !!!

Do not waste your time, managemenst system cannot be corrected a week before audit. I suggest you to go through your key processes like (1) document control (2) management review (3) competenc, awareness and training (4) supplier monitoring and evaliuation (5) control of production and service provision (6) acceptance activity (7) internal audit (8) control of nonconforming product (9) CAPA, and identify gaps and flaws in your system.

We pay the auditor to audit us, they have no intention to disqualified us. To a good auditor, as long as the auditee able to present evidence that the system has been reviewed, gaps identified, and action identified, i believe they will be more willing to change the NC to MNC.

This is not the end, the audit is just a turning point, it is still rely on us what we want to to after the audit, else next year we may have the same problem again. I am sorry because i put in too many personal opinion.

Cheers.
 
K

Ktrna

#17
Just wanted to thank everyone for the advice on this thread....I survived my audit with a few things to fix and now have until December for our re-cert audit!! I've convinced management to let me take some courses now and am getting a better understanding of my role. This forum was a huge help and I am sure I will be back for more advice soon....:thanx:
 
B

Bekka

#19
Hello,
I'm new to the cove but have been registered for awhile. I have been reading the post and discussions here.
My company manufactures and distributes a medical device and we are 13485:2003, and FDA compliance. Our certification is this fall.
I'm very new to auditing and having a problem as to my next course of action. I took a 3 day course on iso 13485:2003 standard to help understand it. My question is we have departments that make up our medical device and I have been auditing those departments but I feel I have missed the "big" picture auditing. I tried to make an audit schedule from the last auditor but they audited agianst only the departments but don't understand how they tied it together. We have Doc control, management review,incoming inspection, shipping and recieveing, purchasing, inventory control and several other key processes that I have identified. Should I make a audit schedule and just do those and if so I how do I tie those to the departments?
 
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